VasoplegiaRAAS-HLMNCT05833828
Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery
An observational study of Vasoplegia and Vasoplegic Shock, run by Universität Münster at 2 sites in Germany.
Trial summary
This study investigates the question of whether there are differences in the plasma concentration of hormones of the RAAS-axis between patients undergoing on-pump cardiac surgery and those receiving off-pump surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasoplegia, Vasoplegic Shock
- What is being tested?
- on-pump surgery and off-pump surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 24 Aug 2023to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University Hospital
Who may be able to join
- adult patients undergoing on- or off-pump coronary artery bypass graft surgery
- written informed consent
Who cannot join
- emergency surgery in the context of acute coronary syndrome
- ACE-inhibitor or Angiotensin 1 (AT1)-receptor-blocker intake that was not paused on the day of surgery
- Chronic kidney disease with estimated glomerular filtration rate (eGFR)<30ml/min/1.73m²
- Severe structural lung disease (asbestosis, silicosis, severe sarcoidosis, tuberculosis, severe emphysema, chronic obstructive pulmonary disease (COPD) Gold 3-4, lung fibrosis)
- Chronic pulmonary hypertension
- Pregnancy or breastfeeding
- Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
- Persons held in an institution by legal or official order
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Deutsches Herzzentrum der Charité
Berlin, 13353
- Recruiting
University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Münster, 48149
Alexander Zarbock, MD
About this study
Official title: Differences in Plasma Concentration of RAAS-axis Hormones in Patients Undergoing Cardiac Surgery With or Without Cardiopulmonary Bypass
This study investigates the question of whether there are differences in the plasma concentration of hormones of the RAAS-axis between patients undergoing on-pump cardiac surgery and those receiving off-pump surgery
Read the detailed description
In patients undergoing cardiac surgery, the occurrence of vasoplegia or vasoplegic shock is a common and sometimes very severe complication. Although there are multiple factors that may affect the incidence and severity of vasoplegia, it remains unclear which role the use of cardiopulmonary bypass may play in the pathogenesis of this complication. The heart normally pumps blood through the lungs where the blood primarily gets oxygenated. However, it is also known that pulmonary blood flow is also essential for the activation of various hormones, some of which are central to the regulation of vascular tension and blood pressure. If the pulmonary circulation is bypassed, as is the case in on-pump cardiac surgery, it is likely that the resulting differential activity of hormones may cause or contribute to the incidence of vasoplegia. This study aims to show whether cardiopulmonary bypass leads to the differential regulation of hormones of the renin-angiotensin-aldosterone-system which could explain why some patients suffer from vasoplegia or vasoplegic shock following such procedures.
- Conditions
- Vasoplegia, Vasoplegic Shock
- Being tested
- on-pump surgery, off-pump surgery
- Keywords
- vasoplegia, vasoplegic shock, cardiopulmonary bypass, cardiac surgery
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on-pump surgeryProcedure or surgery
the surgery will be performed "on-pump"
off-pump surgeryProcedure or surgery
the surgery will be performed "off-pump"
| Study group | Role | What they receive |
|---|---|---|
| on-pump coronary artery bypass graft surgery | Due to the observational design of the study, no study-specific interventions are performed. Except for the above mentioned laboratory analyses, the treatment of the patients is completely guided by the responsible ICU physicians.
Study participation does not influence the determination of surgical procedure (on- vs off-pump). Receives: Procedure: on-pump surgery | |
| off-pump coronary artery bypass graft surgery | Due to the observational design of the study, no study-specific interventions are performed. Except for the above mentioned laboratory analyses, the treatment of the patients is completely guided by the responsible ICU physicians.
Study participation does not influence the determination of surgical procedure (on- vs off-pump). Receives: Procedure: off-pump surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in plasma concentration of Angiotensinogen
Measured: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Renin
Measured: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin I
Measured: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin converting enzyme (ACE)
Measured: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin II
Measured: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Aldosterone
Measured: between induction of anesthesia and immediately after surgical intervention
Secondary outcomes (5)
Differences in plasma concentration of Angiotensin 1-9
Measured: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin 2-7
Measured: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3)
Measured: between induction of anesthesia and immediately after surgical intervention
Incidence of vasoplegia
Measured: within 12 hours post surgery
Cumulative dose of vasopressors
Measured: within 12 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start24 Aug 2023
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasoplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Zarbock, MD, Study chair, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833828
- Sponsor's protocol ID
- AnIt22-08
- Acronym
- RAAS-HLM
- Status last verified
- Dec 2024
- First submitted
- 19 Jan 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Plasma Concentration of RAAS-axis Hormones in Patients Undergoing Cardiac Surgery With or Without Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05833828
- Acronym / sponsor ID
- RAAS-HLM / AnIt22-08
- Conditions
- Vasoplegia, Vasoplegic Shock
- Keywords
- vasoplegia, vasoplegic shock, cardiopulmonary bypass, cardiac surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the question of whether there are differences in the plasma concentration of hormones of the RAAS-axis between patients undergoing on-pump cardiac surgery and those receiving off-pump surgery
Detailed description
In patients undergoing cardiac surgery, the occurrence of vasoplegia or vasoplegic shock is a common and sometimes very severe complication. Although there are multiple factors that may affect the incidence and severity of vasoplegia, it remains unclear which role the use of cardiopulmonary bypass may play in the pathogenesis of this complication. The heart normally pumps blood through the lungs where the blood primarily gets oxygenated. However, it is also known that pulmonary blood flow is also essential for the activation of various hormones, some of which are central to the regulation of vascular tension and blood pressure. If the pulmonary circulation is bypassed, as is the case in on-pump cardiac surgery, it is likely that the resulting differential activity of hormones may cause or contribute to the incidence of vasoplegia. This study aims to show whether cardiopulmonary bypass leads to the differential regulation of hormones of the renin-angiotensin-aldosterone-system which could explain why some patients suffer from vasoplegia or vasoplegic shock following such procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on-pump coronary artery bypass graft surgery | – | Procedure: on-pump surgeryDue to the observational design of the study, no study-specific interventions are performed. Except for the above mentioned laboratory analyses, the treatment of the patients is completely guided by the responsible ICU physicians. Study participation does not influence the determination of surgical procedure (on- vs off-pump). |
| off-pump coronary artery bypass graft surgery | – | Procedure: off-pump surgeryDue to the observational design of the study, no study-specific interventions are performed. Except for the above mentioned laboratory analyses, the treatment of the patients is completely guided by the responsible ICU physicians. Study participation does not influence the determination of surgical procedure (on- vs off-pump). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University Hospital
Key inclusion criteria (2 listed)
- adult patients undergoing on- or off-pump coronary artery bypass graft surgery
- written informed consent
Key exclusion criteria (8 listed)
- emergency surgery in the context of acute coronary syndrome
- ACE-inhibitor or Angiotensin 1 (AT1)-receptor-blocker intake that was not paused on the day of surgery
- Chronic kidney disease with estimated glomerular filtration rate (eGFR)<30ml/min/1.73m²
- Severe structural lung disease (asbestosis, silicosis, severe sarcoidosis, tuberculosis, severe emphysema, chronic obstructive pulmonary disease (COPD) Gold 3-4, lung fibrosis)
- Chronic pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| on-pump surgerythe surgery will be performed "on-pump" | Procedure or surgery | on-pump coronary artery bypass graft surgery |
| off-pump surgerythe surgery will be performed "off-pump" | Procedure or surgery | off-pump coronary artery bypass graft surgery |
Primary outcome
Differences in plasma concentration of Angiotensinogen
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Renin
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin I
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin converting enzyme (ACE)
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin II
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Aldosterone
Time frame: between induction of anesthesia and immediately after surgical intervention
5 secondary outcomes
Differences in plasma concentration of Angiotensin 1-9
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin 2-7
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3)
Time frame: between induction of anesthesia and immediately after surgical intervention
Incidence of vasoplegia
Time frame: within 12 hours post surgery
Cumulative dose of vasopressors
Time frame: within 12 hours post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Zarbock, MD study chair
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasoplegia and Vasoplegic Shock, run by Universität Münster at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Zarbock, MD (+492518347255, aki@anit.uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in plasma concentration of Angiotensinogen (time frame: between induction of anesthesia and immediately after surgical intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.